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Semaglutide

One substance under three brand names, and only one of those brands is approved for weight. Which name is on the box decides what it was approved to do.

Class
GLP-1 receptor agonist
Sold as
Sold as: Wegovy, Ozempic, Rybelsus
Prescription only

Boxed warning

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
  • WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY.

From the approved label

Wegovy

Approved uses
  • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
  • to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity; Adults with overweight in the presence of at least one weight-related comorbid condition.
  • Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
Forms and strengths
  • 2.4 mg/0.75 mL Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.
How it is taken
  • Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals.
  • Inject subcutaneously in the abdomen, thigh or upper arm.
  • In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment.
  • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage.
  • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
  • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly. Important Monitoring and Administration Instructions
Must not be used when
  • Personal or family history of MTC or in patients with MEN 2.
  • Known hypersensitivity to semaglutide or any of the excipients in WEGOVY.
Interactions
  • WEGOVY delays gastric emptying.
  • May impact absorption of concomitantly administered oral medications.
  • Use with caution.
Warnings and precautions
  • Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
  • Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
  • Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
  • Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
  • Heart Rate Increase: Monitor heart rate at regular intervals.
  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.
Common side effects
  • Most common adverse reactions (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
  • most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively.
Pregnancy
Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. Risk Summary Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
How it acts
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation.
Label holder:
A-S Medication Solutions
Label version:

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.

Written by us

How it works

Semaglutide imitates a gut hormone released after eating. It slows how fast the stomach empties and acts on the parts of the brain that register fullness, so appetite falls and meals end sooner. The same action lowers blood sugar, which is why the substance holds approvals in two different fields rather than one.

Original and generic

There is no generic semaglutide in Europe or the United States, and anything advertised as one is not what it claims to be. Compounded copies sold online during shortages have been the subject of repeated regulator warnings, because what is in the vial is not verifiable and the dosing errors reported have been severe.

What it costs

The most expensive category on this site by a wide margin, priced per month rather than per tablet, and covered by health systems only under conditions that vary by country. This is the reason the grey market around it is as large as it is.

How to get it legally

Prescription only everywhere, injected weekly, and dispensed by pharmacies against a prescription that a doctor issues after checking body mass index and medical history. The label sets those entry conditions explicitly, so a service that prescribes without asking for height, weight and history is not following it.

From the approved label

Ozempic: approved for

Approved uses
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
Forms and strengths
  • Injection: 2 mg/3 mL (0.68 mg/mL) for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL (1.34 mg/mL) for 4 doses of 1 mg, and 8 mg/3 mL (2.68 mg/mL) for 4 doses of 2 mg in...
  • Injection: 0.25 mg, 0.5 mg or 1 mg per 0.5 mL in a single-dose prefilled syringe
How it is taken
  • Administer once weekly at any time of day, with or without meals.
  • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly.
  • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose.
  • To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage.
  • If a dose is missed, administer within 5 days of missed dose.
  • Inject subcutaneously in the abdomen, thigh, or upper arm. Important Administration Instructions
Must not be used when
  • Personal or family history of MTC or in patients with MEN 2.
  • Serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC.
Interactions
  • Oral Medications: OZEMPIC delays gastric emptying.
  • May impact absorption of concomitantly administered oral medications.
  • Use with caution.
Warnings and precautions
  • Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC. Discontinue if pancreatitis is suspected.
  • Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored.
  • Never share an OZEMPIC pen between patients, even if the needle is changed.
  • Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary.
  • Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
  • Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. OZEMPIC is not recommended in patients with severe gastroparesis.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue OZEMPIC if suspected and promptly seek medical advice.
  • Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
Common side effects
  • most common adverse reactions reported in ≥5% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation.
Pregnancy
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
How it acts
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.
Label holder:
A-S Medication Solutions
Label version:

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.

Comparison

See also

  1. Ozempic and Wegovy: one substance, two approvalsBoth contain semaglutide. Wegovy is approved for weight management and Ozempic for type 2 diabetes, at different doses. Both labels compared directly.
  2. Mounjaro and Ozempic, compared from both labelsTirzepatide and semaglutide compared from their FDA labels: approved indications, dosing, contraindications and boxed warnings, without a verdict neither label supports.

Questions

Is Ozempic a weight loss medicine?
Its label is a diabetes label. Wegovy holds the weight management approval, at different doses. Both labels are on this page so the difference is visible rather than asserted.
Does weight come back after stopping?
The approved product information describes the treatment as long term. What happens after stopping is a question for the prescriber, and the honest answer is that this is why the label frames it as ongoing rather than as a course.
What is Rybelsus?
Semaglutide as a daily tablet, approved for type 2 diabetes rather than for weight. Same substance, different route into the body, different approval.

Sources

  1. WEGOVY: prescribing informationDailyMed, US National Library of Medicine. Label version 23 April 2024
  2. Ozempic: prescribing informationDailyMed, US National Library of Medicine. Label version 30 July 2026
  3. Drugs@FDA: NDA215256US Food and Drug Administration
  4. Drugs@FDA: NDA209637US Food and Drug Administration
  5. Wegovy: EPAR product informationEuropean Medicines Agency

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